Wireless technology increases the
effectiveness of countless every day functions.
While some simply are about the
convenience factor, like being able to
quickly transmit patient records from
one hospital to another via email, others
have the power to be lifesaving. Medical
device manufacturers know that there is
significant opportunity to incorporate
wireless technology into medical devices.
However, design engineers who are
extremely knowledgeable about the
design of medical devices face a number
of challenges in marrying off-the-shelf
wireless chipsets with proprietary medical
devices in development.

One of the greatest challenges design
engineers face is ensuring their devices
meet three different sets of standards. The
Federal Communications Commission
(FCC) has a list of regulations for manufacturers
wishing to sell telecom,
licensed radio frequency, and low power
transmitters in the United States.
However, many medical design engineers
do not have a background in radio frequency.
This increases the potential for
risk because a transmitter could interfere
with the functioning of the device if
placed incorrectly. (See Figure 1)

Along with FCC regulations, each
wireless carrier has its own unique set of
requirements. Whether using Verizon,
Sprint, AT&T, or others, design engineers
need to determine which carrier
they are going to use prior to chip set
placement. This helps engineers design
the products to the correct specifications
so they meet the requirements of
the specific carrier.

In addition to these wireless requirements,
medical design engineers must
comply with medical industry specifications,
such as IEC 60601-1, IEC 60601-1-2,
MDD, IVDD, and the CB Scheme.

The IEC 60601 Third Edition standard
focuses on risk assessment and essential
performance. While designers are
already familiar with the standard’s specifications,
the standard does not clearly
address devices that integrate wireless
technology. Such gaps in the existing
medical specifications can pose both
safety and performance risks, including
the possible interference of devices using
the same frequency band.

Without a uniform, governing set of
standards tying all of the different requirements
together, designers are left wondering
what tests they should be preparing
for and testing to. The FDA knows that
this disconnect exists and recommends
that manufacturers perform a risk analysis and have their devices verified prior to
their submission for approval. This analysis
would confirm the overall functionality
of the device, ensuring all components
operate safely and successfully in their
intended environment.

The best time to conduct a design
review and determine if any vulnerabilities
exist is at the prototype stage.
However, most medical design engineers
do not have the ability to perform these
tests on their own and require the assistance
of third party testing and certification
laboratories. These service
providers can provide medical design
engineers with the guidance needed to
avoid costly mistakes, meet all necessary
requirements, and safely integrate these
emerging technologies into their latest
product innovations.

This article was written by Nicholas
Abbondante, Transmitter Staff Engineer,
Intertek, Boxborough, MA. For more information,
visit http://info.hotims.com/45604-166.

Question of the Week

This week's Question: This month, the Federal Aviation Administration proposed long-awaited rules on the commercial use of small drones, requiring operators to be certified, fly only during daylight, and keep their aircraft in sight. The ruling,...